Kornimate/medical-research-clean huggingface dataset:
glycocalyx damage in critically ill patients

Conditions: Critical Illness

Summary: the hypothesis to be tested: gcx damage and its dynamics correlate to various patient related factors and to using organ-supporting measures. there is a correlation between length of organ support and gcx damage. the aim of the study: evaluation of the relationship between gcx damage and duration of various organ supporting measures. type of the study: observational. subjects: adult patients admitted to icu and requiring organ supporting therapy. sample size: we plan enrollment of 75 patients on invasive ventilatory support in the duration of least 5 days, 50 patients on renal supporting therapy lasting at least 5 days and 20 patients with target temperature management for neuroprotection. intervention: none data to be recorded and analysed: demographics, type of patients (trauma, post surgical, medical, after cardiac arrest), severity score - apache ii, sofa, fluid balance, presence of delirium, clinical outcome, sublingual microcirculation by sdf imaging at time points: before or at the start of organ support, after 24 hours (day 1), day 3, 5, 7 and/or at discharge or before death, microcirculatory data, and perfused boundary region.


Eligibility criteria:
inclusion criteria: * adult patients admitted to icu * artifitial ventilation * renal replacement therapy * targeted temperatura management exclusion criteria: * pregnant women

Keywords: glycocalyx
efficacy and safety of igpro10 in adults with systemic sclerosis (ssc)

Conditions: Diffuse Cutaneous Systemic Sclerosis

Summary: this randomized, multicenter, double-blind (db), placebo controlled, phase 2 study will evaluate the efficacy and safety of igpro10. the db treatment period will be followed by a 24-week open-label (ol) treatment period. eligible subjects will be randomized at baseline in a 2:1 ratio of treatment igpro10 or placebo in the db treatment period. all subjects who enter ol treatment period will receive igpro10.


Eligibility criteria:
inclusion criteria: * 1. age ≥18 years (male or female) at time of providing written informed consent * documented diagnosis of ssc according to acr / eular criteria 2013 * mrss ≥ 15 and ≤ 45 * disease duration ≤ 5 years defined as the time from the first non-raynaud's phenomenon manifestation * subjects within first 18 months of disease duration from first non-raynaud's phenomenon manifestation. exclusion criteria: * primary rheumatic autoimmune disease other than dcssc, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, mixed connective tissue disorder, polymyositis, and dermatomyositis, as determined by the investigator note: subjects with fibromyalgia, secondary sjogren's syndrome, and scleroderma-associated myopathy or myositis at screening are not excluded * positive anti-centromere autoantibodies at screening * evidence of severe chronic kidney disease with estimated glomerular filtration rate \< 45 ml/min/1.73 m2 (as calculated by the chronic kidney disease epidemiology collaboration equation) or receiving dialysis. additionally, subjects with current confirmed diagnosis of diabetes mellitus and requiring medication, with egfr \< 90 ml/min/1.73m2 will be excluded from the study. * history of documented thrombotic episode eg, pe, dvt, myocardial infarction, thromboembolic stroke at any time note: past superficial thrombophlebitis more than two years from screening is not exclusionary * documented thrombophilic abnormalities including blood hyperviscosity, protein s or protein c deficiency, anti-thrombin-3 deficiency, plasminogen deficiency, antiphospholipid syndrome, factor v leiden mutation, dysfibrinogenemia, or prothrombin g20210a mutation * greater than 3 specified current risk factors for tees (documented and currents conditions): atrial fibrillation, coronary disease, diabetes mellitus, dyslipidemia, hypertension, obesity (body mass index ≥ 30 kg/m2), recent significant trauma, and immobility (wheelchair-bound or bedridden) * ongoing active serious infection at screening (including, but not limited to, pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess) * malignancy in the past 2 years, except for non-melanoma skin cancer, cervical carcinoma in situ, or other in situ cancer if it has been excised and treated within in the past year * known hypoalbuminemia, protein-losing enteropathies, and any proteinuria (defined by total urine protein concentration \> 0.2 g/l) * known iga deficiency or serum iga level \< 5% lower limit of normal
health benefits of whole-body vibration

Conditions: Whole-body Vibration

Summary: the overall goals of this pilot investigation are to determine 1) the feasibility of conducting home based wbv studies, and 2) to determine if sub-acute home based wbv can improve a) exercise capacity, b) conduit- and micro- vascular function, and c) skeletal muscle function.

cardiovascular disease (cvd) is the leading cause of death in the world and many comorbid conditions (i.e. diabetes, obesity) can affect overall cvd risk. there is increasing interest into the role that skeletal muscle health plays in mediating cvd risk, particularly in metabolic disease states (ie. obesity and diabetes). whole body vibration (wbv) has emerged as an exercise mimetic that may be more tolerable than traditional modes of exercise, such as treadmill walking/running or cycling. similar to traditional exercise modalities, wbv can elicit beneficial metabolic effects. in fact, a single bout of wbv increases circulating concentrations of il-6, which correspond with the normalization of glucose and insulin in obese individuals. the proposed pilot investigation will provide the foundation to begin understanding the molecular and physiological mechanisms of how sub-acute wbv can improve overall cvd risk. we hypothesize that home based wbv will decrease cvd risk by improving skeletal muscle and vascular function via a decrease in systemic inflammation.

Eligibility criteria:
inclusion criteria: * men and women (\> 18 yrs old) * all races exclusion criteria: * \<18 years old * clinical diagnosis of hepatic, cardiovascular, or renal disease * diabetic complications (i.e. macrovascular, microvascular, or autonomic) * pregnancy * direct vasoactive medications (i.e. nitrates)
the study of post-operation delirium and prognosis of cardiac surgery patients

Conditions: Delirium

Summary: delirium is the most common neurological complication of cardiac surgery patients and associated with poor prognosis. in recent years, the important role of quantitative electroencephalogram (qeeg) in brain function monitoring is becoming increasingly prominent. the purpose of this study is to evaluate the effect of qeeg in predictive of post-operation delirium and prognosis of cardiac surgery patients.


Eligibility criteria:
inclusion criteria: 1. the patients of cardiac surgery aged ≥18 years 2. signed informed consent exclusion criteria: 1. patients with a history of any neurologic and psychiatric disease 2. cognitive disorder 3. stroke history in three years
effects of sea buckthorn oil on mucous membranes

Conditions: Mucous Membranes

Summary: aim of this study is to investigate the effects of intake of sea buckthorn oil on mucous membranes


Eligibility criteria:
inclusion criteria: * women experiencing vaginal dryness * 55-75 years of age * at least 12 months from menstruation exclusion criteria: * use of estrogen replacement therapy

Keywords: sea buckthorn mucous membrane dryness metabolic syndrome vaginal atrophy
establishment of core competence and training model for dementia case management

Conditions: Dementia

Summary: the purpose of this study is to develop the core competence and training model for case management of dementia. this study is the second phase of the project. the first year is the establishment of the training program and the pilot-test stage. the second year is the project implementation and effectiveness evaluation stage, the intervention effectiveness evaluation of the training course for dementia case managers will be conducted.

the purpose of this study is to develop the core competence and training model for case management of dementia. in the previous year (phase i), the needs and competence assessment stage, the investigators are conducting a survey of the connotation and needs of dementia case management, and explore the role functions and competencies of dementia case managers as the basis for developing the training program. this study is the second phase of the project. the first year is the establishment of the training program and the pilot-test stage. the data collected in the previous period will be integrated to plan a preliminary training program structure, and then the content and training methods of the training program for dementia case managers will be established using the delphi method. then, use this training program to carry out the pilot test of the dementia case managers training program. the second year is the project implementation and effectiveness evaluation stage, the intervention effectiveness evaluation of the training course for dementia case managers will be conducted. the results of this study will serve as a reference for the training program of dementia case managers in future.

Eligibility criteria:
inclusion criteria: * dementia case managers: 1. be at least 20 years old and could communicate in chinese or taiwanese. 2. currently work for dementia center, dementia care center, or community-based dementia care center in taiwan. * dementia family caregivers: 1. be at least 20 years old and could communicate in chinese or taiwanese. 2. primary caregivers 3. the people with dementia under care are diagnosed with dementia clinical dementia rating scale(cdr) 0.5 or higher. 4. live in northern taiwan(including taipei, new taipei, taoyuan, and hsinchu). exclusion criteria: * dementia case managers: no longer working for dementia center, dementia care center, or community-based dementia care center in taiwan. * dementia family caregivers: the people with dementia under care live in a long-term care facility or nursing home.

Keywords: dementia case management core competence training program
importance of magnetic resonance imaging (mri) in treating breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to determine if the use of magnetic resonance imaging (mri) for breast cancer translates into better surgical outcomes. mris may help ensure that as little healthy tissue is removed as is possible and may help prevent the need for additional surgical procedures.

we propose that the role of preoperative staging-mri in breast cancer be studied by following the occurrence of negative margins at first surgery and the volume of resection in a randomized prospective study. the need for re-excision is an objective marker of satisfactory local surgery and is available as soon as the final pathology report is back. we propose that the closest margin and the rate of re-excision be used as the primary outcome measures to evaluate the contribution of mri. in addition, since cosmetic preservation is one of the goals of breast conservation, we propose that cosmetic outcome be used as the secondary outcome measure. the visual analogue scale for cosmetic outcome varies between observers and with time; however, the volume of tissue that is excised is an objective surrogate of cosmetic outcome.15 since the excised volume is dictated by the tumor volume, the only variable under the surgeon's control is the volume of benign tissue excised in order to obtain negative margins. hence, in this study, we propose to use a volume index of excised margins as an outcome measure for cosmesis. the index value will be calculated for each subject by adding the two measurements of benign margin for each of the three dimensions measured and multiplying them to produce a volume index for each subject.

Eligibility criteria:
inclusion criteria: * newly diagnosed breast cancer patients * breast cancer patients identified as conservation candidates by their surgeons exclusion criteria: * patients with a history of prior breast cancer treatment (recurrence) * patients with breast cancer diagnosis during pregnancy (women who could bear children must have a negative pregnancy test before beginning this study) * patients with documented sensitivity to gadolinium (contrast agent used during mri) * patients who weigh more than 350 pounds (weight limit on mri machine) * patients who receive neoadjuvant chemotherapy * patients with renal insufficiency (serum cr \> 1.5) due to the danger of nephrogenic systemic sclerosis with the administration of gadolinium

Keywords: breast cancer magnetic resonance imaging
efficacy of over-glasses patch treatment for amblyopia in children : opta study

Conditions: Amblyopia

Summary: this is a study to investigate efficacy of over-glasses patch treatment for amblyopic children using visual function improvement and amblyopia treatment index (ati) changes.

in a randomized multi-center controlled clinical trial, children younger than 7 years with moderate amblyopia (visual acuity in the range of 20/40 to 20/100) would be included to receive treatment with either a conventional patch or an over-glasses patch. the patients will be prescribed 2 hours of patching per day for the sound eye. best-corrected visual acuity (bcva) and stereopsis will be investigated and ati questionnaires be collected from parents at 5 weeks and 17 weeks after the initiation of treatment.

Eligibility criteria:
inclusion criteria: 1. moderate amblyopia (logmar visual acuity in the amblyopic eye 0.3 to 0.7 inclusive) 2. logmar visual acuity in the sound eye of 0.1 or better 3. intereye acuity difference of larger or equal to 0.3 of logmar visual acuity 4. the presence of or a history of an amblyogenic factor meeting study-specified criteria for strabismus and/or anisometropia. exclusion criteria: 1. presence of an ocular cause for low vision 2. myopia greater than -6.0 diopters (d) spherical equivalent in either eye 3. prior intraocular or refractive surgery 4. treatment for amblyopia (other than spectacle correction) within the 6 months prior to the enrollment 5. down syndrome
study evaluating the safety and tolerability of rct1100 in healthy and pcd subjects

Conditions: Primary Ciliary Dyskinesia

Summary: this is the first-in-human study with rct1100 and is designed to provide initial safety and tolerability data for future clinical studies.

the primary objective of this study is to assess the safety and tolerability of a single ascending dose of inhaled rct1100 administered via nebulizer to healthy participants and patients with primary ciliary dyskinesia caused by a pathogenic mutation in the dnai1 gene.

Eligibility criteria:
major inclusion criteria: * healthy, adult, male or female of, 18-75 years of age, inclusive, at screening. * participant has disease causing mutations in the dnai1 gene * the participant has a forced expiratory volume in one second (fev1) of at least 50% predicted. major exclusion criteria: * history or presence of clinically significant medical, surgical, clinical laboratory, or psychiatric condition or disease. * history of cancer, with exception of adequately treated basal cell or squamous cell carcinoma of the skin. * medically significant hemoptysis * anticoagulation therapy for the treatment of a pulmonary embolus or has had a pulmonary embolus in the last 6 months of screening. * active tuberculosis infection. * laboratory abnormalities in clinical laboratory tests at screening: 1. serum creatinine level 2. total bilirubin, aspartate aminotransferase or alanine aminotransferase values 3. hematological or coagulation values outside the normal reference range * any medical history of disease that has the potential to cause a rise in total bilirubin over the uln * history of alcohol abuse or drug addiction with the last year of screening. * active smoker (vaping included). other protocol defined inclusion/exclusion criteria may apply.

Keywords: primary ciliary dyskinesia pcd kartagener syndrome
a risk assessment and management program using telecare consultation among patients with diabetes mellitus

Conditions: Diabetes Mellitus

Summary: telecare consultation, which is defined as a two-way synchronized visual (voice and image) communication between patients and healthcare professionals using telecommunication applications such as zoom, has become a major trend in recent years. the current covid-19 pandemic provides an impetus to drive change and increase the uptake of telecare consultation in healthcare. to the best of investigators' knowledge, there is no translational research available that simultaneously implements and evaluates the telecare model of care delivered in a primary care setting. the present study will be the first in hong kong to fill this service and knowledge gap in the care of dm patients.


Eligibility criteria:
inclusion criteria: * aged 18 or above, having a confirmed diagnosis of diabetes, having regular follow-ups in the clinic exclusion criteria: * having dementia, having unaccompanied hearing or vision loss, not having an internet connection at home

Keywords: diabetes mellitus telecare consultation
programmed death-1(pd-1) inhibitor combined with progesterone treatment in endometrial cancer

Conditions: Endometrial Cancer Stage I

Summary: we want to make a comparison of pd-1 inhibitor combined with progesterone versus progesterone alone in the treatment of early stage endometrial cancer patients who want to preserve fertility.

approximately 63,400 new cases of endometrial cancer are diagnosed annually in china. while the initial treatment for early-stage disease is surgical staging with lymphadenectomy, it is apparently inappropriate for young patients who want to preserve fertility. currently the standardize treatment for these patients are high-dose progesterone, which will be effective in approximately 40\~70% patients. mirena have been used recently as a new available treatment option, however, no concrete evidence shows it is more effective than the traditional progesterone treatment. pd-1 inhibitor has been utilized as a salvage treatment in many cancers including ovarian cancer, cervical cancer, lung cancer, gastric cancer and endometrial cancer. as endometrial cancer showed high microsatellite instability-high/deficient mismatch repair (msi-h/dmmr) rates, it is assumed to be highly responsive to pd-1 inhibitor treatment. published clinical trial results showed that pd-1 inhibitor treatment was effective in 6/24 late-stage endometrial cancer patients, with little or mild side effects. here we want to investigate the efficacy of pd-1 inhibitor combined with progesterone in early stage endometrial cancer patients who want to preserve fertility.

Eligibility criteria:
inclusion criteria: 1. early endometrial cancer patients (cancer confined in the endometrium, endometrioid histology, g1-2) 2. patients want to preserve fertility 3. informed consent acquired 4. age \ = 45 5. eastern cooperative oncology group (ecog) performance status score \<=1 6. normal blood routine test 7. normal hepatic and renal function 8. normal thyroid function 9. patients willing to accept three times of hysteroscopy: before treatment, 3 months after treatment, 6 months after treatment. 10. pregnancy test negative before treatment exclusion criteria: 1. patients are receiving immune-checkpoint inhibitor therapy 2. patients need or request to receive other anti-cancer drug treatment such as chemotherapy 3. patients are allergic to immune-checkpoint inhibitor agents 4. patients have abnormal blood routine test results or impaired hepatic and renal functions 5. patients have a history of cardiovascular disease, including severe hypertension, frequent cardiac arrhythmia, history of myocardial infarction 6. patients have a history of hepatitis b or hepatitis c infection, with detectable virus load 7. severe obstructive lung disease 8. autoimmune disease 9. need to receive daily corticosteroid or other immune-inhibitory agents 10. active tuberculosis patients 11. patients have a history of other malignant tumors 12. patients with acute infectious disease
assessment of ssd in outpatients by using sss-cn

Conditions: Somatization Disorder

Summary: about 70-80% of patients with somatic symptom disorder (ssd) visit the general medical hospital instead of psychiatric or other mental health settings. the current self-reporting questionnaires are neither sufficiently considering companioned anxiety or depression nor validated for monitor the treatment efficacy of such group. the somatic symptom scale-china (sss-cn) is developed due to the urging clinical demanding in general hospital. the study aims to investigate whether the sss-cn could serve as a timely and practical instrument to detect ssd and assess the severity of the disorder.

one of the most common medical conditions seen in general hospital is somatic symptoms disorder (ssd). as the disorder is characterized by the prominent attention to somatic concerns, patients mainly present initially in medical rather than mental health care settings. the fifth edition of the diagnostic and statistical manual of mental disorders (dsm-5) is currently the "gold standard" for the diagnosis of ssd, but it is clinically hard to follow. thus, it is more clinically practical to detect a disorder by self-administered questionnaires, that patients can score symptoms according to their own condition and severity in a short time. however, the current self-reporting questionnaires, such as the patient health questionnaire-9 (phq-9), the generalized anxiety disorder scale-7 (gad-7), and the patient health questionnaire-15 (phq-15) are neither sufficiently considering companioned anxiety or depression nor validated for monitor the treatment efficacy of ssd patients. the somatic symptom scale-china (sss-cn) is developed based on dsm-5 to assess ssd, and it is an abbreviated 20-item version of somatic symptoms that can be entirely self-administered by the patient, but its assessment value has not yet been widely tested. the study aims to investigate whether the sss-cn could serve as a timely and practical instrument to detect ssd and assess the severity of the disorder.

Eligibility criteria:
inclusion criteria: 1. age 18-80 years old; 2. patients who have no previous diagnosed somatic disease; 3. patients without systemic disease that can account the physical discomfort; 4. patients who agree to take the checklists and undertake assessment from a physician. exclusion criteria: 1. patients who have lost their self-assessed abilities or refuse to participate in; 2. patients who have been previously confirmed serious mental disorders, mental retardation or dementia; 3. patients who are taking anti-anxiety agents or anti-depression agents; 4. patients who are unable to complete at least 1 time follow-up.

Keywords: somatic symptom disorder the somatic symptom scale-china mental disorders management